MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-08-12 for 4C PLUS COULTER CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[15207696]
Customer reported a potential biohazard when the control vials of a 4c plus coulter cell control kit were found to be leaking. A small amount of the control leaking onto the vial caps while still inside the container. This appeared to be due to loose vial caps. The operator was wearing appropriate personal protective equipment of gloves and safety glasses. There was no exposure of the material to open wounds or mucous membranes. No reports of death or serious injury, and no affect to operator safety as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15796227]
Torque test records for the vial lots in this kit demonstrated passing results. A review for similar events was conducted. There have been four reports of leaking for this product from 2005 to 2010. Root cause was not determined. This reportable event was identified during a retrospective review conducted between 01/01/2008 and 10/23/2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01133 |
| MDR Report Key | 2229280 |
| Report Source | 01,05,06 |
| Date Received | 2011-08-12 |
| Date of Report | 2010-03-14 |
| Date of Event | 2010-03-14 |
| Date Mfgr Received | 2010-03-14 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2012-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4C PLUS COULTER CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-08-12 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 1000302K |
| ID Number | NA |
| Device Expiration Date | 2010-04-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-12 |